Replies to post #460958 on Anavex Life Sciences Corp (AVXL)

[abew4me]

Quote: Either way, it is also my understanding that MAA is moving forward without waiting for any OLE data.

How did you come to this understanding?

I can't imagine them making a decision without the OLE. What was the percentage of patients from the original n=509 that requested to be in the OLE? (Wasn't something like 90%?)

[boi568]

I agree that the small size of the trial should not determine its fate with the EMA.

The issues are efficacy and safety. Despite the small n, the drug performed quite well regarding efficacy. The trial size is a major issue at the design phase, where a company faces the possibility that a given n may be too small to provide a statistically significant successful outcome. We are past that point here; the AD 2b/3 has now provided that result.

The other issue, demonstrating safety, may require a Phase 4 trial from a regulator, given the vast market and the relatively few data points yet available. However, Anavex will be able to provide other safety data for blarcamesine at this dosage from other trials and OLEs to supplement the 2b/3 findings. Based on the MOA and patient history, there is no reason to worry much about this potential problem even if there is a need for a Phase 4.